Identify and Manage Preoperative Causes of Wrong IOL Placement
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Summer 2008
Every ophthalmologist has heard stories of the wrong eye being enucleated or the wrong procedure being performed. the Joint Commission’s Universal Protocol (UP)—preoperative verification, site marking, and time-out— was developed to prevent such cases. While the UP is capable of catching 85% of “wrong” errors in ophthalmic procedures performed in hospitals and surgery centers, it does not address the cause of wrong IOLs, the most frequent type of surgical confusion in ophthalmology.[1] As John Simon’s study shows, 25% of IOL mistakes originate in the physician’s office.
Q When I examined my cataract surgery patient at his first postoperative visit, his refractive outcome (+3 D) was not what I had expected. I reviewed the medical record and discovered that I had implanted the wrong IOL. I informed the patient of the error, apologized, offered to refund the cost of the procedure, and disclosed the treatment options. What else should I do?
B Your honest and compassionate discussion with the patient will go a long way to helping him through the postoperative period. studies show that in addition to a truthful account- ing and an apology, patients also want to know that you will take steps to protect others from the same outcome.[2] One method proposed by patient safety experts is to inform your patient that you will conduct an event analysis that exposes not only the error that occurred in this instance, but potential mistakes in the sequence of care that could culminate in choosing or implanting the wrong IOL in another patient.
Q I already know what happened! My new technician made a mistake during the A scan. Should I fire her?
A While firing an employee involved in an error that harmed a patient is an understandable initial reaction, it does not address your role in training her, may send your staff the wrong message, and could lead to the loss of your best ally in preventing future errors. Your technician no doubt feels as badly as you do about this outcome. Rather than allowing her to shoulder the entire blame and punishing her, you can show staff that you take ultimate responsibility for the care provided in your office, as well as for hiring, training, and supervising them. Indeed, you can show them how to use mistakes as a learning opportunity. Call a meeting and explain that wrong IOLs are the most frequent type of error and cause of malpractice claims in cataract surgery. Ask for their assistance in reviewing office practices. Ask the technician to be part of the effort to analyze the event. Invite her to tell her story, and then explain how you dealt with the patient. You and your technician will thus demonstrate your commitment to the patient, the staff, and to improving the quality of your care.
Q What are the next steps in the event analysis?
A Ask your staff to map out the entire office-based sequence of events involved in choosing and ordering an IOL. You might want to have two teams, one that focuses on the clinical process (A scan and choice of IOL) and one that studies the administrative sequence of events (transferring the physician’s order to the ASC or hospital, informed consent, etc.). Experts suggest establishing two timelines: one for how the process is actually done and one for how it should be done.[3] Once the team is sure that all of the steps are noted, it brainstorms on how this part of the sequence can go wrong, thus beginning the “hazard analysis” part of the review, which also includes determining the effect, severity (impact on the patient), probability, and detectability of the “failure.” The hazard analysis helps the team determine which errors in care constitute critical failures and these become the focus of your efforts to design a safer process.
Q Has anyone analyzed “wrong IOLs” this way?
A I have not seen a formal failure mode and effects analysis, but there are several studies of wrong IOLs. Dr. Simon’s article on surgical confusion cited earlier explains some common causes, and the AAO/ASORN and American Association of Eye and Ear Hospitals have identified ways to prevent wrong IOL. In addition to ensuring adequate training of personnel and calibration of equipment, the AAO/ASORN/ASEEH report suggests that you instruct your staff to test both eyes and then compare the results of each eye to itself and to the other eye (in the same eye, the difference between the two scans should be ≤ 0.2mm, while between eyes it should not exceed 0.3mm unless the patient is known to have anisometropia).[4] Verify the results of the IOL Calculation Report and the formula used to pick the IOL yourself, and take a copy to the OR. Assign two staff members to compare the results to the preop orders sent to the ASC.
Pediatric Sedation for Office-Based Procedures
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Summer/Fall 2004
Ophthalmologists are performing an increasing number of diagnostic and therapeutic procedures in office settings. While most of these are done under local anesthesia, some require sedation and analgesia both in order to accomplish the procedure and to ensure the comfort of the patient. There are important safety concerns when care traditionally rendered by anesthesiologists or CRNAs in hospitals with back-up emergency staff and equipment is provided by non-anesthesia personnel in offices. Using administration of chloral hydrate (CH) to pediatric patients as an example, this article will address some of the risks of office-based sedation and offer recommendations for reducing them.
Q The practice I joined administers chloral hydrate to pediatric patients in order to conduct examinations. Is CH considered safe?
A While CH is widely used “off label” for the sedation of infants and toddlers and has a reputation as a safe medication with minimal effects on respiration, an analysis of adverse pediatric sedation incidents found that 13 out of 60 cases resulting in death or permanent neurologic injury involved the use of chloral hydrate alone or in combination with other medications.[1] Factors contributing to the outcomes included overdosage, administration at home, administration by non- medically trained personnel (technicians), and premature discharge from medical observation. Unlike some opioid medications used for sedation, CH has no known reversal agent, and a very long half-life in children (27.8 +/- 21.3 hours in newborns, 9.7 +/- 1.7 hours in toddlers). Without the stimulation of the examination, the sedating effect returned; children suffered respiratory compromise that went unnoticed by the parent, often during the car ride home.
Q Could the deeper level of sedation be prevented by giving the correct dose?
A Not necessarily, since some of the children who were injured had received the appropriate amount. As the American Society of Anesthesiologists’ “Practice Guidelines for Sedation and Analgesia by Non- Anesthesiologists” warns, sedation is a continuum. Four levels have been identified, based upon responsiveness, the airway, spontaneous ventilation, and cardiovascular function: minimal sedation (anxiolysis), moderate (formerly known as “conscious sedation”), deep sedation, and general anesthesia.[2] The Guidelines clarify that since it is not always possible to predict how an individual patient will respond, practitioners intending to produce a given level of sedation should be able to rescue patients whose level of sedation becomes deeper and causes hypoventilation, apnea, airway obstruction, or cardiopulmonary impairment.[3] Proper monitoring can detect these problems, but the training and expertise needed to recognize these complications and rescue the patient from them are usually not part of the skill set of most ophthalmic personnel. Accordingly, CH is usually administered only in the hospital setting. Increasingly, it is being replaced by reversible IV agents that also provide better pain relief.
Q What measures should I take to protect children receiving sedation?
A Ask the anesthesiology department of your local hospital to help you devise an office-based sedation protocol that addresses drug and patient selection criteria, dosing regimen based upon the child’s weight, NPO (nothing by mouth) guidelines, monitoring and discharge criteria, and rescue practices and equipment (see also the ASA and AAP guidelines referenced in the footnotes below). The order for the medication should include the child’s weight, the mg/kg dose, and the total dose to be administered. Never allow pre-procedure administration at home. After the procedure, observe the child in a quiet monitored area, even if he or she seems to be completely awake immediately after completion. This is especially important when using medications with long half-lives (chloral hydrate, promazine, promethazine, chlorpromazine, phenobarbital).[1] Use only qualified personnel whose training and competency include cardiopulmonary assessment, airway management, and resuscitation to monitor the child during and after the procedure and to determine if the child meets discharge criteria. Provide oral and written discharge instructions for the adult accompanying the child home that address expected behavior, eating, warning signs of complications, special instructions in case of an emergency, and how and when to contact you.[2,3]
1. Cote,Charles J et al. “Adverse Sedation Events in 2. Pediatrics: Analysis of Medications Used for Sedation.” Pediatrics 2000: 106; 633-644.
2. American Society of Anesthesiologists. “Practice Guidelines for Sedation and Analgesia by Non- Anesthesiologists,” approved 17 October 2001, available online at https://ecommerce.asahq.org/p-180-practice-guidelines-for-sedation-and-analgesia-by-non-anesthesiologists.aspx See also the ASA “Sedation Model Policy.”
3. American Academy of Pediatrics, Committee on Drugs. “Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures.” Pediatrics, v. 89, n. 6, June 1992. See also American Academy of Pediatrics, Committee on Drugs, “Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures: Addendum.” Pediatrics, v. 110, n. 4, October 2002.
“Standing Order” Medications
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Fall 2011
Most surgeons develop preferences for instruments, sutures, viscoelastics, and medications. To facilitate efficient preparation and turnover in operating rooms, they inform the hospitals and ambulatory surgery centers where they have privileges of what they would like to have available for each type of surgery. OMIC claims experience shows that certain aspects of these standing orders, especially medications, need to be made part of the surgical briefing. Medication errors are among the most frequent types of mistakes, and three types of medications top the charts: antibiotics, steroids, and anticoagulants. unfamiliarity and interruption in the preparation process, along with failure to label drugs and verify them when handing them to another provider to administer, all increase the likelihood of error.
Q My antibiotic standing order is not difficult to prepare. Do I really need to discuss it?
A It would be prudent. In one OMIC case, the standing order was for cefazolin (Ancef) IV. The ophthalmologist assumed it had been prepared as ordered, so when the certified registered nurse anesthetist (CRNA) asked him if he wanted her to “give this,” he agreed without any safety check. The patient developed respiratory distress immediately after administration of what turned out to be polymixin sulfate IV, a medication that was not on his order, should not be given intravenously, and causes respiratory paralysis from neuromuscular blockage. The reversal agent given to counteract the neurotoxin was contraindicated with polymixin, and potentiated its action; the patient needed intubation and two days in the hospital to recover. In another case, the standing order was for gentamycin to be diluted in 500 cc basic saline solution. Two patients whose procedures were back-to- back presented in the office with signs of aminoglycoside toxicity of the retina the day following surgery. The investigation showed that the nurse had erroneously prepared a much higher concentration of the drug. Both patients ended up NLP. In all three cases, the ensuing lawsuits named the hospitals, nurses, anesthesia providers, and ophthalmologists as defendants.
Q Why am I as the surgeon held responsible for the errors of nurses and anesthesia providers?
A Diligent plaintiff attorneys initially name all possible defendants, though surgeons may at times be dismissed if no act or omission on their part contributed to the adverse outcome. In the above-mentioned cases, defense experts sympathized with the surgeons’ reliance on the correct interpretation and execution of their standing orders, but felt that the physicians could have done more to protect the patient. Patient safety experts would say that they helped sustain a climate where errors not only went undetected but were likely to happen. Whether the surgeon is ultimately held liable depends upon the facts of the case, the venue, and the willingness of other parties to settle cases. The surgeon in the first case did not clarify the CRNA’s question. Nonetheless, since his standing order did not contain polymixin, the case against him was dismissed, while the CRNA and hospital settled. The second surgeon was criticized for ordering a medication with known toxic side effects when safer medications were available (OMIC made a modest contribution to a settlement on his behalf). As surgeon, you can actively create safety twice: include a brief discussion of intraoperative medications you or the nurses will administer as part of the time out [“Let’s review the antibiotic: cephazolin (Ancef) 1 gram IV.”] and confirm the drug label one last time as it is handed to you if you will be administering it.
Q What steps can the surgical team take to increase the safety profile of higher-risk medications?
A Medication safety protocols can reduce many possible sources of errors by addressing known risk issues and building in redundancy and verification. Surgeons should review standing medication orders on a periodic basis to confirm choices. Ask for new, dated cards whenever you change orders. Instruct the hospital or ASC to remove former orders from patient care areas and store them where they can be accessed only by administrators. Include precise preparation steps, and appropriate warnings, in the standing order to ensure proper route and concentration. Ensure that the facility provides nurses with a quiet area to review orders and prepare drugs with access to medical records and without interruption. Require that every medication and fluid needed for the specific procedure be labeled with drug, dosage, dilution, route, etc., and consider having medication vials available in the OR to confirm drug choice. Insist that nurses who prepare medications regularly demonstrate adequate medication knowledge and competency in preparation. Create a culture of safety where everyone feels comfortable asking for assistance with unfamiliar medications or processes and questioning orders they do not understand.
PAM Testing Before Cataract Surgery
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Summer 2003
A policyholder called OMIC to ask if PAM (Potential Acuity Meter) testing is required before cataract surgery in patients with coexisting eye disease, such as macular degeneration or glaucoma. This question raises important risk management issues about elective surgery. A medical malpractice claim focuses on the following aspects of care: indications for surgery (preoperative evaluation and diagnosis); type of procedure planned (choice of procedure, technique, implant); candidacy for surgery (coexisting ocular and medical conditions, known risk factors for complications and poor outcomes); informed consent (disclosure and documentation of risks, benefits, alternatives); performance of the procedure (technique, recognition, management, disclosure of complications); and postoperative care (discharge condition and instructions, postop visits and telephone calls, recognition and management of complications and poor outcomes). This article focuses on indications and informed consent. The next Risk Management Hotline will address risk reduction when performing elective surgery on a patient with serious medical comorbidities.
Q What are the indications for cataract surgery in the adult?
A The American Academy of Ophthalmology’s Preferred Practice Pattern (PPP), “Cataract in the Adult Eye,” states that surgery is indicated if visual function does not meet the patient’s need and there is a reasonable likelihood of improvement with surgery. The ophthalmologist would, therefore, need to determine, disclose, and document that the cataract is responsible for the vision loss and verify and document that the cataract-induced vision loss has led to an inability to function. The PPP points out that patients with ocular comorbidities such as glaucoma or macular degeneration tend to have poorer outcomes after surgery. The ophthalmologist should determine, disclose, and document the impact of cataract-related vision impairment on these preexisting ocular comorbidities in order to carefully manage the patient’s expectations about the likely benefits of surgery.
Q Is PAM testing required?
A Some evaluation of potential visual acuity is needed. The PPP discusses various types of subjective (such as PAM) and objective potential acuity tests and concludes that there “is no significant evidence that demonstrates that these tests predict the outcome of cataract surgery more reliably than clinical examination.” The actual type of potential acuity evaluation is less important than doing one and informing patients that the predicted results may not match the actual outcome. A PAM may or may not be helpful. Corneal topography, ultrasound, hard lens over refraction, and clinical examination all play an important role, as does evaluation of the patient’s distance and near vision, and consideration of such issues as glare.
Q How should I handle the discussion if the patient is at high risk for complications or a poor outcome?
A First, personally obtain the patient’s informed consent. This legal duty cannot be delegated. During the discussion and documentation process, it is crucial to explain the effect of ocular and medical comorbidities and other known risk factors on the likelihood of complications during and after the procedure and on the final outcome. Use a procedure-specific consent form. Circle or underline the appropriate section of the consent and write in the reasons for the increased risk (e.g., hemorrhage if anticoagulants cannot be stopped for medical reasons; rupture of the posterior capsule with dense cataracts). See Closed Claim Study on opposite page.
Explain that conditions such as glaucoma, diabetes, and macular degeneration can impact visual acuity and functionality. Inform the patient that while the acuity evaluation indicates that he/she is likely to benefit from surgery, potential acuity testing may not accurately predict the results. Even though you recommend surgery, no guarantee can be made that visual acuity will improve.
Q How can I verify that the patient understands the risks and the likely outcome?
A Patients are understandably anxious and fearful during these discussions and may only hear portions of what you say. Have the patient sign a procedure-specific consent form. Keep the original document in the patient’s record and give the patient a copy. Ask the patient to review the document at home with family members and to call your office if there are questions. Your staff can play a valuable role in verification, either when the form is signed or the surgery is scheduled, by asking patients what procedure will be done and why. If the patient does not appear to understand, you can discuss the procedure again and clear up any confusion. You or your staff can document the repeat discussion and the fact that the patient now understands and consents.
Clarification of Roles During the Informed Consent Process
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Fall 2005
Recently, OMIC revised its sample consent form for cataract surgery, partly in response to the new “multifocal IOLs” and partly to better prepare patients for the procedure and defend ophthalmologists against allegations of lack of informed consent. Soon after the form revision was announced in our E-Bulletin and the AAO Express, policyholders began calling with questions about the roles they, their office staff, and the ASC play in the informed consent process.
Q I just reviewed OMIC’s new cataract consent form. Do you really expect me to review all six pages with each of my patients?
A The short answer is no. A more complete response should help clarify the phases of the informed consent process and the roles played by various members of the health care team. As the surgeon, you have a legal duty to obtain the patient’s informed consent, which is best understood as an oral agreement you reach with the patient after the informed consent discussion. This face-to-face talk addresses the ophthalmic condition and the risks, benefits, and alternatives—including no treatment—of the proposed procedure. The discussion must always take place before the patient signs any consent form, while the patient is awake and aware, and free from the effects of any medication that could interfere with his or her ability to participate in the decision-making process. The form itself serves to document and verify that the informed consent discussion with you took place. Neither the form nor any video or teaching aids can substitute for the face-to-face talk with the surgeon.
Q Do I have to mention all known risks during my discussion?
A No. The standard discussion most ophthalmologists conduct is rarely as detailed as a procedure-specific consent document and usually consists of a summary of this information. You do, however, need to address any particular concerns of the patient as well as any condition that puts the patient at increased risk, and then write a brief note in the medical record. To help educate the patient and provide more details about the surgery, OMIC recommends that you give patients a copy of the procedure-specific consent form. Some practices ask the patient to read it before the preoperative meeting with the surgeon; others have a staff member go over it with the patient afterwards.
Q Can my staff members witness the patient’s signature even if they were not present during the discussion?
A Yes, since what is being witnessed is the patient’s signature. While they cannot obtain the patient’s informed consent, staff members play an invaluable role in patient education. As a risk management measure, staff members should ask patients what procedure will be done and why before asking them to sign the form. If the patient does not appear to understand, staff members should inform you so that you can discuss the procedure again and clear up any confusion or misunderstanding. Staff members can then document that you discussed the procedure again with the patient and that the patient appeared to understand and signed the consent.
Q Can I just use the consent form at the hospital or ambulatory surgery center (ASC)?
A No, since that form’s primary purpose is to document that the ASC or hospital has fulfilled its own, separate legal duties. The ASC or hospital cannot obtain the patient’s informed consent for the procedure you are performing; only the ophthalmologist can do that. Hospitals and ASCs must verify, however, that the surgeon obtained informed consent before allowing the procedure or surgery to take place. ASCs and hospitals also have a separate duty to obtain what is known as general consent for the care and treatment provided at their facility by their employees and other providers, e.g., the anesthetist. There is no discussion of specific risks or benefits of the ophthalmic procedure when obtaining this general consent. ASCs and hospitals often use a single form both to verify that the surgeon obtained informed consent and to obtain general consent for care rendered at their facility. The patient is usually given this form to sign by a facility employee during the registration or admission process. To protect themselves against allegations of lack of informed consent, therefore, ophthalmologists should have the patient sign the procedure-specific consent form in their office and place it in the patient’s medical record.
